The following data is part of a premarket notification filed by Bahadir Usa Corp. with the FDA for Bahadir Sterilization Trays.
Device ID | K112090 |
510k Number | K112090 |
Device Name: | BAHADIR STERILIZATION TRAYS |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | BAHADIR USA CORP. 275 WEST HOFFMAN AVENUE Lindenhurst, NY 11757 |
Contact | Ismail Kilic |
Correspondent | Ismail Kilic BAHADIR USA CORP. 275 WEST HOFFMAN AVENUE Lindenhurst, NY 11757 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-21 |
Decision Date | 2012-06-07 |
Summary: | summary |